Ipergay: On-Demand PrEP Study Design

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Imogene Fields
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1 On Demand PrEP with Oral in MSM Results of the ANRS Ipergay Trial Molina JM, Capitant C, SpireB, Pialoux G, Chidiac C, Charreau I, Tremblay C, Meyer L, Delfraissy JF, and the ANRS Ipergay Study Group Hospital Saint-Louis and University of Paris 7, Inserm SC1-US19 Villejuif, Hospital Tenon, Paris, Hospital Croix-Rousse, Lyon, UMR912 SEAS Marseille, France, CHUM, Montreal, Canada and ANRS, Paris, France Abstract 23LB Ipergay: On-Demand PrEP Study Design Double blind, randomized placebo controlled trial to prevent HIV infection in France and Canada HIV negative MSM Anal sex without condoms with 2 partners in past 6 months egrf >6 ml/min Prevention services before and after sex* (n=199) Prevention services before and after sex* (n=21) Follow-up visits: month 1, 2, and every 2 months thereafter Endpoint driven study with 64 infections there is 8% power to detect 5% reduction in infection rate in active arm Expected incidence 3/1 PY with placebo *Two tablets 2-24 hours before sex; 1 tablet 24 hours later; 1 table 48 hours later

2 Ipergay: Baseline Characteristics Characteristics (Median, IQR) or (n, %) n=199 n=21 Age (Years) 35 (29-43) 34 (29-42) White 19 (95) 184 (92) Completed Secondary Education 178 (91) 177 (89) Employed 167 (85) 167 (84) Single 144 (77) 149 (81) History of PEP Use 56 (28) 73 (37) Use of Psychoactive Drug in Past 12 Months 85 (44) 92 (48) Circumcised 38 (19) 41 (2) Infection with Gonorrhea, Chlamydia, Syphilis 43 (22) 59 (29) # Sexual Acts in Prior 4 Weeks 1 (6-18) 1 (5-15) # Sexual Partners in Prior 2 Months 8 (5-17) 8 (5-16) Ipergay: Risk Behavior 2 Median # of Sexual Acts (Last 4 weeks) % 1 Anal Intercourse W/O Condom J M2 M4 M6 M8 M1 M12 M14 M16 M18 M2 M22 M24 (389) (349) (35) (281) (222) (186) (154) (14) (126) (115) (13) (88) (51) Median # of Sexual Partners (2 Months) J M2 M4 M6 M8 M1 M12 M14 M16 M18 M2 M22 M24 (336) (292) (256) (233) (188) (157) (13) (119) (15) (97) (86) (67) (72) % Receptive Anal Intercourse W/O Condom J M2 M4 M6 M8 M1 M12 M14 M16 M18 M2 M22 M24 (395) (352) (314) (269) (234) (19) (157) (143) (131) (116) (17) (93) (85) J M2 M4 M6 M8 M1 M12 M14 M16 M18 M2 M22 M24 (28) (166) (151) (14) (19) (85) (69) (65) (57) (5) (5) (36) (38)

3 Ipergay: Time to HIV Infection Probability of HIV-1 Infection N at Risk: Log-rank test p= D Months Infections: : 14 (incidence: 6.6 per 1 PY) : 2 (incidence:.94 per 1 PY) Relative Reduction: 86% (95% CI: 4 99%, p=.2) Number needed to treat for one year to prevent one infection: 18 Ipergay: Number of Pills Used Per Month Visits N part. Percentage of participants M1 382 M2 352 M4 315 M6 288 M8 M1 M12 M14 M16 M18 M2 M22 M24 M26 M28 M Nb pills used / month ]25-3] ]18-25] ]11-18] ]4-11] ]-4] : full bottles returned (all tablets) missing : 294/2798 visits (1.5%) Median number of pills/month (IQR): 16pills (1-23) in the placebo arm and 16 pills (12-24) in the arm (p=.84) 48 participants (12%) received PEP 25 (13%) in the arm and 23 (11%) in the placebo arm (p=.73)

4 Ipergay: Adherence Assessed by CASI PrEP Use During the Last Sexual Intercourse 1212 Sexual Intercourses Assessed in 319 Participants % PrEP Use (Min-Max) n=649 Acts n=563 Acts Total % (min-max) Correct Use* 45 (36-57) 4 (22-49) 43 (35-51) Suboptimal Use 27 (14-35) 31 (18-44) 29 (2-38) No PrEP 27 (15-37) 29 (24-44) 28 (2-38) *According to the protocol, or at least one pill before and one pill after sex. Ipergay: Adverse Events Nb of Participants (%) n=199 n=21 P-value Any AE 184 (92) 178 (89).18 Any Serious AE 18 (9) 16 (8).7 Any Grade 3 or 4 AE 17 (9) 14 (7).56 Treatment D/C Due to AE 1* Drug-Related GI AEs 25 (13) 11 (6).13 Nausea/Vomiting 15 2 Abdominal Pain 11 4 Diarrhea 7 5 *Deep veinous thrombosis with suspected DDI with dabigatran

5 Ipergay: Conclusions On demand PrEP reduced HIV acquisition by 86% (95% CI: 4-99) HIV incidence was higher in the placebo arm than anticipated Safety of on-demand was similar to placebo except for gastrointestinal symptoms and Grade 1 changes in creatinine No evidence for risk decompensation PROUD: Open-Label PrEP Trial HIV negative, MSM engaging in unprotected anal intercourse in past 9 days in London, UK Willing to take a pill a day No contraindication to use of Immediate PrEP Daily N = 276 Deferred PrEP until week 48 N = 269 Follow-up at 3 month intervals Post-exposure prophylaxis provided McCormack S, et al. 22nd CROI; Seattle, WA; February 23-26, 215. Abst. 22LB.

6 PROUD: HIV Incidence Group No. of Infections Follow-Up (PY) Incidence (Per 1 PY) 9% CI Overall Immediate Deferred Efficacy = 86% (9% CI: 58 96%) P value =.2 Rate Difference =7.6 (9% CI: ) Number Needed to Treat =13 (9% CI: 9 25) McCormack S, et al. 22nd CROI; Seattle, WA; February 23-26, 215. Abst. 22LB.

Condoms, PrEP, and the use of ART to prevent the sexual transmission of HIV: Overview of the science and recommendations for service providers

Condoms, PrEP, and the use of ART to prevent the sexual transmission of HIV: Overview of the science and recommendations for service providers James Wilton Coordinator, Biomedical Science of HIV Prevention